China Identifies Five Priority Risk Monitoring Items for Cosmetics

On September 14, 2024, China National Medical Products Administration (NMPA) released a draft of the Administrative Measures on Cosmetic Safety Risk Monitoring. ¹ Subsequently, on April 9, 2025, the NMPA issued the finalized version, titled Administrative Measures on Cosmetic Safety Risk Monitoring and Evaluation (hereinafter referred to as the “Measures”), which will take effect on August 1, 2025. ²

The Measures applies to the safety risk monitoring and evaluation of cosmetics and toothpaste. It consists of 33 articles across six chapters: general provisions, plan formulation, sampling and inspection, referral and investigation of potential issues, application and evaluation of monitoring results, as well as supplementary provisions.

The Measures aims to replace the Working Rules for Cosmetic Risk Monitoring implemented in January 2018. Compared to the previous Rules, the Measures provides more detailed and comprehensive guidelines for cosmetic risk monitoring. The key points of the Measures are as follows.

1. Clarifying responsibility division and monitoring objectives

Cosmetics risk monitoring refers to the inspection and testing activities of medical products administration (MPA) departments to monitor, analyze and effectively manage risk factors that may impact the quality and safety of cosmetics. The goal is to identify and prevent quality and safety risks, thus to provide a scientific basis for developing quality and safety control measures, conducting sampling inspections, and communicating potential safety concerns.

The Measures outlines the responsibilities of NMPA, National Institutes for Food and Drug Control (NIFDC) and local MPAs:

• NMPA is responsible for overseeing the national management of risk monitoring and evaluation. Its duties include organizing and implementing nationwide risk monitoring and evaluation initiatives, establishing a national information system for risk monitoring and evaluation, and formulating the national monitoring and evaluation plan;

• NIFDC is tasked with providing technical support for national risk monitoring and evaluation. It is also responsible for organizing and coordinating the implementation of specific monitoring and evaluation activities at the national level;

• Provincial and local MPAs are responsible for developing localized risk monitoring and evaluation plans and carrying out related activities within their respective administrative regions.

2. Specifying key monitoring products and items

Risk monitoring and evaluation prioritizes the following factors that may impact the quality and safety of cosmetics:

1. Substances commonly added to cosmetics that may pose risks to human health;

2. Substances that could affect the health of vulnerable groups, such as children;

3. Risk substances that are introduced through raw materials or packaging materials, or that may be generated or introduced during the production, storage, or transportation of cosmetics;

4. Items involved in the standards to be formulated or revised;

5. Other critical monitoring items.

3. Defining risk monitoring process

The Measures outlines the risk monitoring process, which includes the following steps: sampling, inspection and testing, result reporting, investigation and handling, risk control, and case filing. 

Sampling should be conducted at the cosmetics operation stage through purchase, either on-site or online. The number of samples should generally meet inspection and testing requirements. The sampling units and personnel must not notify cosmetics operators in advance.

The sampling information shall include, but is not limited to, the following details: the name and address of the sampled entity, product name, name and address of the cosmetics registrant, notifier, and entrusted production enterprise, cosmetics production license number, special cosmetics registration certificate number or general cosmetics notification number, and expiration date.

During the sampling process, if the sampling unit identifies any of the following suspected violations, it shall report the relevant information to the MPA:

• Sale or import of unregistered special cosmetics, or unnotified general cosmetics, or have expired;

• Absence of Chinese labeling;

• Labels containing prohibited content;

• Other suspected illegal cosmetic products.

If all samples pass inspection, the testing institution should submit a testing report to the MPA within seven working days. If any non-compliant samples are identified, the testing institution must submit relevant materials to the MPA within two working days. The MPA will then assess the problematic samples, investigate safety risks associated with the cosmetics, and may require the involved enterprises to carry out self-inspection and rectification or implement appropriate risk control measures. If any manufacturer or operator is suspected of legal violations, a case will be filed for investigation.

4. Application and evaluation of monitoring results

MPAs will implement the following risk management measures based on specific circumstances:

With the implementation of the Measures, “risk identification” becomes the first crucial step in the full life cycle management of cosmetics. To remain competitive in the evolving regulatory landscape, enterprises must continuously invest in ingredient screening, product manufacturing, factory testing, and emergency response mechanisms.

Further Reading

• The NIFDC Consults on the Draft Guidelines of Updating Notification Information of NCIs

• Exporting Perfumes to China: Key Compliance and Import Requirements